The Obviousness of Preamble Limitations Can be a Real Headache for Patent Challengers
In Eli Lilly And Company v. Teva Pharmaceuticals, Appeal No. 20-1876, the Federal Circuit held that in claims for methods of using apparatuses or compositions, statements of intended purpose in a preamble tend to be limiting.
Lilly filed petitions for IPR against three Teva patents directed to methods for alleviating migraines. The Board concluded that Lilly had failed to show that the challenged claims would have been obvious over the asserted references. While the Board found that Lilly had shown that the prior art disclosed every element of the challenged claims, and a motivation to combine the prior art, Lilly had not shown that a skilled artisan would have had a reasonable expectation of success in combining the references. Lilly appealed.
On appeal, Lilly argued that the Board incorrectly found that Teva’s preambles were limiting because a preamble that contains only a statement of purpose cannot as a matter of law be a claim limitation. The Federal Circuit disagreed, and explained that unlike apparatus and composition claims, claims to methods of using apparatuses or compositions are not directed to what the method “is,” but typically rely entirely on what the method “does.” And what a method does is usually recited in its preamble. Thus, statements of intended purpose in methods of using apparatuses or compositions tends to result in a conclusion that such preamble language is limiting.
Lilly also argued that the Board had imposed a heightened standard – one that required efficacy data – in its analysis of whether the prior art references would have given a skilled artisan a reasonable expectation of success. The Federal Circuit disagreed that the Board imposed such a standard. The Federal Circuit also made clear that a showing of a reasonable expectation of success need not rely on clinical data, nor must it include a demonstration of certainty that the treatment would be successful in every instance.
Twisting a Nose of Wax While Splitting Hairs
In Commscope Technologies LLC v. Dali Wireless Inc., Appeal No. 20-1817, the Federal Circuit held that when a party distinguishes technology in the prior art to preserve validity, that same technology may not simultaneously be grounds for infringement when in an accused product.
CommScope filed suit against Dali alleging infringement of five of CommScope’s patents. Dali counterclaimed, alleging CommScope infringed two of Dali’s patents. The jury rendered verdicts of infringement, no invalidity, and damages for both parties. CommScope and Dali each appealed following the district court’s denial of their respective motions for judgment as a matter of law, a new trial, and attorney’s fees.
Dali’s ‘521 patent at issue described a system and method for digital predistortion of signals. Specifically, the patent described an operating mode requiring: “switching a controller off to disconnect signal representative of the output of the power amplifier.” The district court construed this term to mean “[s]witching a controller to a nonoperating state to disconnect signal representative of the output of the power amplifier.”
First, the Federal Circuit rejected Dali’s challenge to the district court’s claim construction, noting that an argument made only in a footnote is forfeited. Even if the argument had been properly raised, it was insufficiently developed. Seeing no meaningful challenge from Dali, the Federal Circuit adopted the district court’s construction.
Second, the Federal Circuit turned to noninfringement, finding that Dali cited no evidence showing that the switch, the controller, or a combination of the two are put into a “nonoperating state” in the accused product. Moreover, CommScope argued that Dali did not dispute testimony from CommScope’s expert that both the switch and controller are continuously operating; instead, it merely explained why that operation infringed. The Federal Circuit rejected Dali’s argument that this distinction was “splitting hairs.”
Third, the Federal Circuit determined that Dali’s infringement argument could not stand in light of its arguments of no anticipation. Dali distinguished the prior art by arguing that the patent required “a controller that controls a switch and places itself and the switch in a non-operating state in order to disconnect the output from the training circuit.” However, in its argument that CommScope’s technology infringed the patent, Dali argued that “CommScope’s premise that the controller itself must be turned off is . . . literal nonsense.” The Federal Circuit found the case fell squarely within the principle that “a patent may not, like a nose of wax, be twisted one way to avoid anticipation and another to find infringement.” Accordingly, the Federal Circuit reversed the denial of CommScope’s motion for JMOL of noninfringement and affirmed the denial of CommScope’s motion for JMOL of invalidity.
Presumption of Nexus Between Claims and Commercial Products May Not Apply When Unclaimed Features Are Critical
In Teva Pharmaceuticals v. Eli Lilly And Company, Appeal No. 20-1747, the Federal Circuit held that the presumption of nexus analysis requires the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products.
Eli Lilly challenged three patents directed to humanized antagonist antibodies in IPRs. The PTAB held that the challenged claims in all three patents were unpatentable as obvious over various cited references.
The Federal Circuit affirmed the PTAB’s decision after finding substantial evidence supported the PTAB’s finding of a motivation to combine the teachings of the references, and that potential safety and efficacy concerns would not have dissuaded a skilled artisan from making the claimed antibodies to study their therapeutic potential.
The Federal Circuit also affirmed the PTAB’s finding of no presumption of nexus between the challenged claims and the commercial products even though the PTAB articulated an incorrect standard. The Federal Circuit noted that the nexus-presumption analysis requires the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products. In this case, the PTAB correctly found that a nexus was not presumed because the unclaimed features were critical to the functionality of the commercial products.